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Inspection Readiness Lead

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POST DATE 9/7/2016
END DATE 11/8/2016

Shire Pharmaceutical Lexington, MA

Lexington, MA
AJE Ref #
Job Classification
Full Time
Job Type
Company Ref #
Mid-Career (2 - 15 years)
Bachelors Degree


Job Description
Under the direction of the Head of QMS Systems and Logistics, this position s responsibilities include, but are not limited to; retrieving information from applicable R&D QMS technologies in support of regulatory authority requests either prior to, during or after an inspection, contributing to the inspection readiness toolkit, etc.

Key member of the R&D QA&C Inspection Readiness Team

Works in close collaboration with global R&D departments to implement procedural and compliance related trainings in support of the R&D QMS.

Fosters a culture of continuous improvement and identifies opportunities to further enhance quality and compliance using process and technology.

Leads activities related to inspection preparedness and execution:
* Works in close collaboration with global R&D departments to conduct
inspection readiness training including the use of SharePoint or other tools for document tracking.
* Facilitates and works closely with functional areas to compile information for Health Authority Dossiers.
* Work with key members of R&D to compile and maintain a list of R&D
Inspection Team Members.
* Active member in preparing for and facilitating mock inspections.
* Coordinate inspection activities with the study teams.
* Notify internal and external stakeholders about relevant inspection plans and activities.
* Ensure adherence to document request procedures prior to, during and after the inspection
* Ensure adequacy and availability of facilities and equipment necessary to conduct the inspection.
* Support preparation of daily summary reports during inspection process.

* Leads project initiatives as defined by the Head of QMS Systems and Logistics.
* Provides operational and compliance support and direct support for internal / external audits and inspections as appropriate.
* Manages the Security Call List for Shire R&D globally, updating on an annual basis.
* Manages and maintains the development of inspection readiness tools shared area (e.g. SharePoint site) where electronic documents can be staged, as needed

Serves as a member of the R&D Quality Operations Leadership Team to influence the operational strategy of the R&D QA & Compliance function.
Identifies, develops, and drive continuous improvement opportunities.

* Executes on the short- and long-term R&D QA&C Quality Operations strategy as defined by the Head of QMS Systems and Logistics through defining short- and long-term strategies specific to R&D QMS technologies.
* Alerts senior management of significant deficiencies in R&D QMS processes and technologies and works with Shire personnel and business partners on optimization and corrective actions and preventative actions.

Bachelor s degree in a science, business or technical related field is required.
* Previous experience in inspection support is required.
* Minimum 5 years in R&D, Inspection Lead or Quality Assurance in a Pharmaceutical environment is desirable.
* Knowledge of US, EU, ICH regulations, guidance s and requirements.

Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We have best-in-class products available in more than 100 countries across core therapeutic areas including Hematology, Immunology, Neuroscience, Lysosomal Storage Disorders, Gastrointestinal / Internal Medicine / Endocrine and Hereditary Angioedema; a growing franchise in Oncology; and an emerging, innovative pipeline in Ophthalmics.

Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.

Shire is an equal opportunity employer. Shire evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

EEO is the Law
EEO is the Law - Supplement
Pay Transparency Policy

Reasonable Accommodations
Shire is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.